Las Palmas De Gran Canaria

Researchers are evaluating the use of personalized, dynamic titanium prostheses made with 3D printing to reconstruct the chest wall after tumor removal or severe trauma. This study addresses the challenges of traditional rigid reconstruction methods that can cause pain or breathing difficulties by testing implants designed to mimic natural rib movement, potentially improving function and comfort. The study is a multicenter, ambispective registry collecting both retrospective and prospective data across major Spanish hospitals. The treatment involves creating a custom 3D-printed titanium prosthesis based on preoperative CT scans, manufactured using titanium alloy powder. During surgery, the prosthesis is implanted and anchored to the ribs or sternum to restore chest wall integrity while preserving natural dynamics. The study includes retrospective cases and prospective enrollment over 24 months, with follow-up evaluations at discharge, 1 month, 6 months, and 12 months post-surgery. Participants will undergo assessments including pulmonary function tests, pain scales, imaging like X-rays and CT scans, and quality of life questionnaires. Data is securely stored and anonymized in a centralized database compliant with European data protection laws. The primary outcomes measure changes in lung function parameters over one year. Participants can withdraw at any time, and the study aims to improve prosthesis design and surgical practices through comprehensive monitoring and analysis.

Preterm birth, defined as birth before 37 weeks of gestation, occurs in about 8 percent of pregnancies in Canada and is linked to many health challenges, especially when it happens before 29 weeks. At this early stage, infants often face breathing difficulties and may require resuscitation. This trial compares resuscitation using either low 30% or high 60% oxygen levels to determine which approach results in better survival and neurodevelopmental outcomes at around 24 months of age. The study uses a cluster randomized crossover design where hospitals alternate between starting resuscitation with 30% or 60% oxygen for groups of 30 infants. Resuscitation includes standard care steps like lung expansion and ventilation support as needed. Oxygen is initially given at the assigned concentration for the first 5 minutes, then adjusted based on the infants oxygen saturation levels and heart rate over the next 5 minutes to maintain target saturation ranges. This approach aims to balance risks of too much or too little oxygen. Participants are infants born between 23 and 28 weeks gestation who receive full resuscitation at participating centers. During the study, infants have oxygen saturation monitored continuously, and adjustments to oxygen concentration are made carefully. Researchers will evaluate survival and major neurodevelopmental outcomes at 24 months corrected age, along with several safety and health measures during the neonatal intensive care stay. The trial is expected to provide important evidence to guide oxygen use during resuscitation of extremely preterm infants.

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.

Researchers are investigating new treatments for extensive-stage small cell lung cancer ES-SCLC, a type of lung cancer that has spread widely within the lungs or to other parts of the body. This study evaluates the combination of two study medicines, gocatamig and I-DXd ifinatamab deruxtecan, with or without standard chemotherapy and immunotherapy. The research aims to understand the safety and tolerance of these combinations and whether they can shrink or eliminate tumors in people with ES-SCLC. Participants are assigned to one of several treatment groups. Some receive gocatamig and I-DXd during maintenance after completing standard chemotherapy and immunotherapy, while others receive these study medicines during both induction and maintenance phases. Additional groups receive gocatamig and I-DXd followed by gocatamig and atezolizumab, or standard treatment with carboplatin, etoposide, and atezolizumab followed by atezolizumab maintenance. Treatments are given intravenously and continue until disease progression or other study-specified criteria. During the study, participants will have regular assessments to monitor safety, side effects, and treatment response, including scans to measure tumor size and laboratory tests to evaluate drug levels and immune response. The study will track adverse events, treatment tolerability, and cancer control over up to approximately 58 months. Participants health status and responses to the treatments will be closely observed throughout this period, with periodic evaluations to understand long-term effects and outcomes.

Researchers are studying new treatment options for people with high-risk non-muscle invasive bladder cancer HR NMIBC, including cases with carcinoma in situ CIS. HR NMIBC affects the lining of the bladder but has not spread to muscle or beyond. The study aims to learn if adding intismeran autogene V940 to the standard Bacillus Calmette-Guerin BCG immunotherapy can improve outcomes by helping the immune system attack the cancer more effectively. Participants are divided into groups receiving different treatments. One group Cohort A receives both intismeran autogene via intramuscular injection every 3 weeks for 9 doses and BCG instillations weekly in specific weeks over about 75 weeks. Another group receives only BCG following the same weekly schedule. A third group Cohort B receives intismeran autogene alone every 3 weeks for 9 doses. The study evaluates these treatments over several years. During the study, participants will have regular treatments and follow-up visits where researchers will monitor cancer progression, recurrence, and survival for up to approximately 5 years. Assessments include event-free survival, recurrence-free survival, overall survival, response rates, time to cystectomy, and safety outcomes such as adverse events and treatment discontinuation. The study is randomized and open-label, with detailed long-term monitoring planned.

Researchers are investigating new treatments for locally advanced or metastatic urothelial cancer UC, a type of bladder cancer that has spread or cannot be removed by surgery or radiation. This trial evaluates whether sacituzumab tirumotecan sac-TMT, an experimental medicine, can help people with UC who have already been treated with specific therapies live longer compared to those who receive certain non-platinum chemotherapy options. The study is a Phase 3 randomized trial comparing sac-TMT with chemotherapy drugs selected by the investigator. Participants are assigned to one of two groups one receives sacituzumab tirumotecan at a dose of 4 mgkg every two weeks by intravenous infusion until the disease worsens or side effects become unacceptable. The other group receives one of three chemotherapy drugspaclitaxel, docetaxel, or vinflunineby intravenous infusion every three weeks, also until disease progression or unacceptable toxicity. Rescue medications may be given as needed to manage side effects according to approved guidelines. During the study, participants undergo assessments of overall survival up to about 40 months, along with other measures such as progression-free survival, response rates, duration of response, and quality of life evaluations using questionnaires. Safety is monitored by recording adverse events and treatment discontinuations. The total study participation may last several years, with regular evaluations to understand the effects and tolerability of the treatments.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.

Researchers are evaluating the long-term safety and effectiveness of APG777 in adults with moderate-to-severe atopic dermatitis who have completed treatment in a previous APG777 study. This phase 2 extension study involves participants who, according to their doctors, would benefit from continued treatment with APG777. The study is designed as a multicenter, double-blind trial to assess ongoing treatment outcomes and safety over several years. Participants in this study will continue receiving APG777 through three main periods a screening visit coinciding with the last visit of the prior studys maintenance period, an extended treatment period, and a post-treatment follow-up period. Participants who met certain skin improvement criteria and did not use topical rescue medication during the prior study will maintain their previous dose and injection frequency. Those who did not meet these criteria or used rescue medication will receive APG777 according to a specific dosing plan in an open-label escape arm. During the study, participants will be closely monitored for treatment-emergent adverse events up to 3 years. The research team will also measure skin improvements using tools such as the Eczema Area and Severity Index EASI and the Investigator Global Assessment for Atopic Dermatitis vIGA-AD, as well as tracking itch severity, use of rescue therapy, and serum drug concentrations. The overall participation time includes up to 3 years of follow-up to evaluate long-term safety and efficacy outcomes.

Researchers are evaluating ELVN-001, an investigational drug, in adults with chronic myeloid leukemia CML, including those with a specific T315I mutation. This early-phase trial aims to find safe and tolerable doses for further study, especially in patients who have relapsed, are resistant, or cannot tolerate current tyrosine kinase inhibitors TKIs. The study also examines how ELVN-001 affects disease markers and its overall safety profile. The trial includes a dose escalation phase to identify recommended doses, followed by dose expansion phases that treat patients with or without the T315I mutation at those doses. ELVN-001 is given orally once or twice daily. Participants receive the drug as a single agent, and the study monitors responses and safety during these phases. Participants will undergo regular assessments including monitoring for side effects, laboratory tests, heart evaluations, and measurement of molecular responses related to CML over periods ranging from 28 days up to 3 years. The study tracks drug levels in the body for up to 6 months and evaluates long-term outcomes such as complete blood responses. Overall participation duration varies, with close safety follow-up throughout.